Abstract:

The research presented here is premised on the assumption that in order to evaluate the
risks and benefits, the desirability and ethics of a technology, we must know how it is
likely to interact with its context. The research aims to identify the contexts relevant to
the implementation of biopharming in New Zealand and to investigate whether and how
the associated risks can be managed. It does this by eliciting relevant knowledge from
people with experience and expertise in the identified contexts.
Animal biopharming is defined here as the farming of transgenic animals genetically
modified to produce pharmaceutical compounds for use in humans. Plant biopharming is
also under development. Biopharming is one of several methods that can be used to
produce the class of drugs known as biopharmaceuticals. Animal biopharming research
and development have focused primarily on dairy species.
The major drivers internationally for the development of animal biopharming are its
potential to lower the costs of drug production, the greater ease of upscaling and
downscaling production, an anticipated shortage of manufacturing capacity using other
production methods, the potential to address some of the limitations of other production
methods, and the desire to strengthen or evade patent restrictions. In New Zealand, major
drivers include New Zealand’s animal-health status, the strength of its dairy research and
farm management, and a desire to use biopharming as a tool to move the economy away
from commodity production and to enhance economic competitiveness. Biopharming
research and development in New Zealand is currently focused on dairy cows.
Significant uncertainties remain regarding the potential benefits and hazards of
biopharming. These include: cost-effectiveness in relation to competing platforms,
unresolved technical problems, patent and regulatory issues, potential risks to human
health, issues of gene spread, and animal-welfare concerns.
Factors to be considered when assessing the prospects, including the risks and benefits, of
biopharming in New Zealand should include the nature of the biopharming enterprise
(e.g., animals used, activities encompassed, and operational and ownership structure) as
well as the risk management measures likely to be applied. Four scenarios have been
developed for assessment based on these factors.
Factors relevant to risk assessment and management of biopharming emerging from the
research encompass implications of the farm context for risk management as well as
impacts of risk management on farm practice. The former include: impact of ownership
structure, social and economic influences on implementation of controls, labour market,
and the role of human error. The latter include: grazing practices, disposal of carcasses
and waste, farm location, movements on and off the farm, and future land use.
Application of the research findings to the scenarios suggests that there are substantial
obstacles in the way of animal biopharming being taken up by dairy farmers in New
Zealand. Specialist integrated biopharm operations may not face the same obstacles, but
may also not offer the prospective benefits that have driven research on biopharming in
New Zealand. Application of the findings to risk assessment and risk management points
to a need to include a wider range of knowledge in risk-assessment processes and to
consider a wider range of factors in assessing risks and benefits and in developing risk management
protocols.[Show full abstract]